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***OFFICIAL CYDY/Leronlimab Thread*** (1 Viewer)
- Thread starter This_Guy
- Start date
I know I'm done for a while, but I suspect there are enough traders with this on the radar to keep it propped up. I may set some stupid low buy limits in case we get a short attack.
General Malaise
Footballguy
Honest question - and I ask this as a guy hanging on to 500 little shares in the hopes that maybe this thing is a legit drug - why would ANYBODY be a "long term" buyer of this thing with Nader serving as pilot?
If this drug is legit, an activist investor needs to swoop in, boot management out and run this thing the way a well run publicly traded stock should be managed. Nader is THE key reason why I remain entirely skeptical of this thing and won't ever make another purchase. Get this donkey out of the cockpit.
Have at it shorts. Do your thing. My limits are set all the way down to $3.51. We'll see how much I own this afternoon.
Dwayne Hoover
Footballguy
They are going to unblind data in a month, we have a huge need for a therapeutic right now. Nader cannot derail good results, really the least of worries in the short term.
Just like you said, if this proves efficacy, it's going to have the attention of some big players. Nader is a short term problem.
ChiefD
Footballguy
arrow1
Footballguy
I really appreciate your insight so don’t take this the wrong way, but who the heck is trading CYDY based on technical analysis?I really appreciate your insight so don’t take this the wrong way, but who the heck is trading CYDY based on technical analysis?
Zegras11
Footballguy
Do shorts respect technical analysis or are technical just too much for them to overcome?Figured you more than anyone on the planet would be.
does pink sheet status impact this stuff?
Zegras11
Footballguy
Dunno. All I know is when I saw the opening, I calculated what I posted and was not surprised at all to see it go down to 4.50 and then bounce back up off that. Stocks do that type of thing all the time until you count on them to do it. LOL.
Like how you use to buy the opening and sell an hour later.
Play the trend until it is no longer a trendPlay the trend until it is no longer a trend
Zegras11
Footballguy
General Malaise
Footballguy
I worked 8 years for a dedicated short seller who was an ardent believer in technical analysis. It wasn't his only tool for trading, but he had very expensive chart books delivered to his house every Sunday morning with hundreds of company charts updated weekly in there. He'd flip through them all day and gather inspiration. "Man with the Golden Gut" was his nickname, but he believed fervently in chart reading. 2007 was the best financial year of my life trading for him.
General Malaise
Footballguy
chet
Footballguy
Dwayne Hoover
Footballguy
The one thing that continues to bother me is that other companies get assistance from the government and from what I can tell, nobody seems to care about this one.
Merck now has a therapeutic moving along for severe-critical that the government is getting behind.
I just don't know how to make anything out of this that isn't negative as Cytodyn gets ignored.
That and the lack of good media exposure. Perhaps all these legit publishers are just blind here but it's always been a red flag that it barely gets covered.
These are the reasons why I will sell some of my stake before any decisions are made. There are obviously things I like but the creeping doubts that have me at far less than 100% conviction will dictate my plan to sell about a 1/3 of what I have.
Merck now has a therapeutic moving along for severe-critical that the government is getting behind.
I just don't know how to make anything out of this that isn't negative as Cytodyn gets ignored.
That and the lack of good media exposure. Perhaps all these legit publishers are just blind here but it's always been a red flag that it barely gets covered.
These are the reasons why I will sell some of my stake before any decisions are made. There are obviously things I like but the creeping doubts that have me at far less than 100% conviction will dictate my plan to sell about a 1/3 of what I have.
Dwayne Hoover
Footballguy
That being said, I seem to have more conviction than CFO Michael Mulholland as I'll be keeping more of my stake than he kept of his. Another red flag for sure.
Dwayne Hoover
Footballguy
Predicting an up day tomorrow going into the long weekend.
Dwayne Hoover
Footballguy
Would be good to get some PR around if any new eINDs are requested. This is a potential positive catalyst as we lead up until the approval dates as well. Any good publicity that come out of eINDs is definitely going to be key.
Dwayne Hoover
Footballguy
It will come back at the close, if not before
ex-ghost
Footballguy
Dwayne Hoover
Footballguy
Zegras11
Footballguy
FDA Provides Guidance for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients Until Trial Data is Unblinded
Download as PDFDecember 24, 2020 7:46pm EST
The agency will also consider eINDs for patients in other hospitals who qualify for inclusion criteria similar to CD12
The CD12 trial completed enrollment with 394 patients on December 16
VANCOUVER, Washington, Dec. 24, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the U.S. Food and Drug Administration (“FDA”) provided guidance to the Company to add an open-label extension to its Phase 3 trial (“CD12”) and specific criteria for the continuation of eINDs for patients meeting the inclusion/exclusion criteria of CD12.
The CD12 protocol will be amended for adding the open-label arm extension and submitted to the FDA on Monday, December 28, 2020. Upon clearance, each CD12 participating clinical trial site will have the option of enrolling additional qualified patients, with all patients receiving leronlimab. Treatment of qualified patients will continue until the trial’s data is unblinded.
The FDA also provided specific guidance for the benefit of physicians seeking an eIND for COVID-19 patients, which must first meet the inclusion/exclusion criteria of the CD12 study, and such criteria will be provided to them in the form of a checklist.
Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer and Head of Clinical Development for CytoDyn, stated, “We are pleased that at a time when COVID-19 cases and mortality continue to increase, the FDA’s thoughtful advice will allow a specified subset of patients access to leronlimab, while we await the results of the randomized placebo-controlled portion of the Phase 3 study. We are committed to work with the FDA and the health care providers to improve the outcomes of COVID patients.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very thankful to the FDA for providing guidance on accessing our drug pending the results of CD12, especially during these unprecedented times. CytoDyn will provide the precise requirements for potential participation in the new CD12 open-label extension and physicians seeking eINDs, while we eagerly await the unblinding of the data. The results of our CD10 trial will not support an eIND request.”
About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the Company is closing down its Phase 2 trial for acute GvHD.
Download as PDFDecember 24, 2020 7:46pm EST
The agency will also consider eINDs for patients in other hospitals who qualify for inclusion criteria similar to CD12
The CD12 trial completed enrollment with 394 patients on December 16
VANCOUVER, Washington, Dec. 24, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the U.S. Food and Drug Administration (“FDA”) provided guidance to the Company to add an open-label extension to its Phase 3 trial (“CD12”) and specific criteria for the continuation of eINDs for patients meeting the inclusion/exclusion criteria of CD12.
The CD12 protocol will be amended for adding the open-label arm extension and submitted to the FDA on Monday, December 28, 2020. Upon clearance, each CD12 participating clinical trial site will have the option of enrolling additional qualified patients, with all patients receiving leronlimab. Treatment of qualified patients will continue until the trial’s data is unblinded.
The FDA also provided specific guidance for the benefit of physicians seeking an eIND for COVID-19 patients, which must first meet the inclusion/exclusion criteria of the CD12 study, and such criteria will be provided to them in the form of a checklist.
Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer and Head of Clinical Development for CytoDyn, stated, “We are pleased that at a time when COVID-19 cases and mortality continue to increase, the FDA’s thoughtful advice will allow a specified subset of patients access to leronlimab, while we await the results of the randomized placebo-controlled portion of the Phase 3 study. We are committed to work with the FDA and the health care providers to improve the outcomes of COVID patients.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very thankful to the FDA for providing guidance on accessing our drug pending the results of CD12, especially during these unprecedented times. CytoDyn will provide the precise requirements for potential participation in the new CD12 open-label extension and physicians seeking eINDs, while we eagerly await the unblinding of the data. The results of our CD10 trial will not support an eIND request.”
About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the Company is closing down its Phase 2 trial for acute GvHD.
Zegras11
Footballguy
Capella
Footballguy
All CD12 trial sites can enroll further patients Leronlimab and I believe but am not positive that those who got the placebo will get the drug.
Very big news and an indication approval is forthcoming. Imo
Have to imagine this is partially why they got coded.
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My big concern is the statement that the results of the phase 2 trial will not support Eind.
Capella
Footballguy
Yea. I’m not sure why he even included that but feels like they’ve completed moved away from the moderate stuff.
edit: somebody said mild to moderates would not be eligible for an emergency ind. Makes sense.
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ex-ghost
Footballguy
Hell, who can wait for Monday. This is fantastic news, at least the parts that you all have explained to me.
ChiefD
Footballguy
Capella
Footballguy
one of those toddler-sized cars he can drive around in. Came with no instructions (a-holes) so I had to wing it. Probably will end up only having 3 working wheels and the radio will pick up the BBC or something. .
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Capella
Footballguy
Dwayne Hoover
Footballguy
I can only think this is very positive. I have no idea what the FDA knows at this point but if they think its okay to give to anyone that fits the criteria at these trial sites than they must be pretty high on leronlimab (in a good way)
